NL-OMON40236
Completed
Not Applicable
A randomized, double-blind, placebo controlled, four-period, cross-over study to evaluate the cognitive effects of single oral administration of roflumilast in aging-related memory impairment - ROF-ALZ_103
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- memory impairment
- Sponsor
- Takeda
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy subject, aged 60 to 80 years, inclusive, at the time of informed consent.
- •2\. Memory performance between 1 to 2 SD below (for Impaired Elderly) and between 0\.5 SD below and 0\.5 SD above (for Healthy Elderly) aged, gender, and education level corrected normative values assessed using the VLT.;For a complete list of all inclusion criteria, please see protocol page 34\.
Exclusion Criteria
- •1\. Subjects with previous or existing major psychiatric symptoms.
- •2\. Subjects received any investigational compound within 30 days prior to the study.
- •3 Subjects received Roflumilast in a previous study or as therapeutic agent.
- •For a complete list of all exclusion criteria, please see protocol page 34/35\.
Outcomes
Primary Outcomes
Not specified
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